Frequently Asked Questions

The Tobacco Product Directive (TPD) is an EU directive that regulates tobacco products, novel tobacco products, and vaping products. All EU member states observe this directive, although some have bespoke enforcement arrangements. The Tobacco and Related Products Regulations (TRPR) transfer the TPD into UK law.

The TPD and TRPR enforce a range of standards which impact the vaping industry. These include limits to the size of liquid bottles and tanks, mandatory product notification and health warnings featured on packaging.

Some elements of these sets of regulations have generated counter-productive, unintended consequences. For example, the 20m/g nicotine strength limit means heavy smokers may not be able to switch to much less harmful vaping products. Likewise, the 10m bottle size limit inconveniences potential switchers and increases waste volume.

The EU has begun a review of the TPD. Now the UK has left the EU, it has a range of options on how to proceed. The Government may continue to observe the current directive, it may update it with aspects of the latest EU directive, or it may diverge from this completely. It can do this through the TRPR. The Department of Health and Social Care has an obligation to review the TRPR by May 2021.

As an Association, the UKVIA fully supports evidence-based regulation that is proportionate and properly sets vaping products apart from tobacco. There are definitely some positive aspects to the TPD and TRPR; they have helped ensure high product standards across the industry and reinforced consumer confidence in some respects. However, there remain a number of negative, disproportionate aspects to the regulations.

The UKVIA welcomes the reviews of the TPD and TRPR, and will be feeding into the review processes to ensure meaningful industry involvement can inform the regulations to keep the vaping industry safe and successful.

Article 5.3 of the World Health Organization’s ‘Framework Convention on Tobacco Control’ (FCTC) is part of an international treaty dealing with the involvement of the tobacco industry in setting tobacco policy. It effectively means that the Government should not engage with the tobacco industry when setting tobacco policy; and where it does this engagement should be transparent and public.

This guidance is sometimes used by public health groups and Government as an excuse not to engage with the UKVIA (or individual companies) on vaping policy. The UKVIA believes that as we do not engage in tobacco specific policy at all, and only advocate on vaping policy (explicitly excluding other ‘novel tobacco’ products such as heat not burn) that 5.3 should not apply to our engagement.

Furthermore, Public Health England policy interpretation of 5.3 cites ‘majority’ tobacco run/owned organisations, which the UKVIA is not – as tobacco members make up a small minority of the membership. We believe that precluding effective industry engagement with government and other public health bodies only serves to worsen the development of vaping policy more widely.

Shortfills are zero-nicotine flavoured e-liquids which are subsequently combined with nicotine. The nicotine added can be flavoured or unflavoured. As shortfills do not contain nicotine themselves, they are not covered under the TPD directive. They therefore avoid the stringent levels of regulatory requirement required of traditional, nicotine-containing e-liquids.

As a result of this loophole, the UKVIA is concerned that some shortfills on the market may contain unsafe or untested levels of ingredients, or which contain ingredients prohibited entirely. The Medicines and Healthcare Products Regulatory Agency (MHRA) has no powers to incorporate zero-nicotine containing liquids into their notification process.

The UKVIA has previously pursued several avenues of Government engagement relating to shortfills on behalf of our members. Despite this, action has been limited. The impact and potential negative consequences of shortfills must be considered as a priority when UK vaping regulation is reviewed.

The UKVIA believes that vaping should never be subject to the same tax regime as smoking, as vaping does not utilise tobacco. Any additional cost impediment to the purchase of vaping products risk disincentivising smokers from exploring harm reduction alternatives.

In August 2018, we successfully lobbied the Treasury to abandon plans for a vaping tax in the UK, which could have cost consumers tens of millions of pounds a year and driven down sales.

The Commons Science and Technology Committee confirmed their backing for special consideration on taxing vaping products that same month:

“The level of taxation on smoking-related products should directly correspond to the health risks that they present, to encourage less harmful consumption. Applying that logic, e-cigarettes should remain the least-taxed and conventional cigarettes the most, with heat-not-burn products falling between the two.”

However, vaping continues to attract a full rate of VAT at 20%. This is a marked contrast to NRT products, which attract a 5% rate. The UKVIA continues to press the case for reductions in tax on vaping products, to ensure that their potential for improvement in public health is realised.

As recently as June 2020, we have written to the Chancellor of the Exchequer to ask that vaping is also considered for this reduced rate of VAT.

E-Cigarette/Vaping Associated Lung Injury (EVALI) became prominent in the media after a spate of cases in the US. Often associated with breathing and lung conditions, hospitalisation and fatalities were attributed to EVALI in all states across America. In September 2019, US President Donald Trump made a statement on vaping, interpreted by many as signalling the beginning of a legislative and regulatory clamp down on the sector in the US.

Subsequent analysis revealed that almost all cases of EVALI involved the use of THC oils and black-market products. These liquids are illegal in the UK, where standards are incomparably higher.

The US Centre for Disease Control and Prevention (CDC) has confirmed that the prime cause of the injuries and fatalities from EVALI was the use of vitamin E acetate as a thickening agent. In January 2020 Dr Brian King, Chief Science Officer at the CDC, said:

 “Recommendations were refined to reflect the best available scientific evidence and to best protect public health…The available science shows that Vitamin E acetate is strongly linked (to the reported illnesses)” 

Again, this practise is illegal in UK vaping products. Public Health England has rightly drawn a distinction between the situation in the USA and the UK; as in the UK there is a rigorously regulated market overseen by the MHRA, which monitors banned ingredients.

While vaping products are currently required to be part of the MHRA notification scheme, they are not supplied by the NHS or GPs to patients on prescription. There is a clear harm reduction benefit from vaping devices to smokers, but the UKVIA and others do not feel that medical licensing is necessarily the most effective route to delivering this.

The success of the UK vaping sector is due in part to its reputation as the provider of an innovative consumer product, rather than a traditional medicine. Vapers often report unease at being categorised as a patient, or in some other way receiving formal medical treatment.

The actual process of full medical licencing would also require considerable investments of time and money, which would likely strain those supplying the industry. Furthermore, the length of clinical trials would leave the industry ill-placed to react to changing consumer demands.

While the UKVIA continues to engage with regulators and other bodies on these issues, we do not envisage the pursuit of medically licencing vaping products as being beneficial for smokers.

 

It doesn’t matter whether the product was sold to an underage person unknowingly, as an offence with strict liability, enforcers need only identify a breach in the law. The owner of the business, as well as the member of staff who sold the product, can both be held responsible for the offence. The penalty can include a fine of up to £2,500 and the removal of your license. Retailers must prove that they have taken all reasonable precautions and exercised all due diligence in preventing underage sales.

A proxy sale is where an adult buys, or attempts to buy, tobacco, cigarette papers or a nicotine vapour product on behalf of someone under the age of 18.

Passport, Photo Driving License, a Proof of Age Standard Scheme (PASS), Military ID or Foreign ID.

No – so long as you can prove that you have verified age during the order process, you will not need to verify age upon delivery. However, retailers must implement at least one method of age verification and you might find that verification at the point of delivery suits your business model.

 No – the process of verifying age online must involve the presentation of some form of identification, which is checked against an official database.

A refusals register is a record kept for every time you refuse a sale, where the customer has failed to present valid identification, or is under suspicion of performing a proxy sale. The register should record: date and time of refusal; the name of the staff member who refused the sale; and the reason for refusals.

Yes, the UKVIA and Trading Standards have jointly published a guide to preventing under age sales in store and online. A copy of the guide can be downloaded here.

UKVIA members are a good source of knowledge and can share their experiences.

When sourcing new supplies of any e-cigarette or e-liquid product, check that a compliant notification has been published in one of the Notified Product lists above.

If you cannot find the product on the MHRA’s website, ask your supplier to confirm that it has been published and provide details to enable you to confirm the products status. If a product has yet to achieve publication status, they may not supply it to you.

The MHRA is the competent authority for a notification scheme for e-cigarettes and refill containers in Great Britain and Northern Ireland and is responsible for implementing the majority of provisions under Part 6 of the Tobacco and related Products Regulations (TRPR) and the Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020.

  • Restrict e-cigarette tanks to a capacity of no more than 2ml
  • Restrict the maximum volume of nicotine-containing e-liquid for sale in one refill container to 10ml
  • Restrict e-liquids to a nicotine strength of no more than 20mg/ml
  • Require nicotine-containing products or their packaging to be child-resistant and tamper evident
  • Ban certain ingredients including colourings, caffeine and taurine
  • Include new labelling requirements and warnings
  • Require all e-cigarettes and e-liquids be notified to the MHRA before they can be sold

You must check that the products have a valid ECID number, and that the product has been published on the MHRA’s notified products list which can be found on their website.

No. Not until such time as the notification has been approved and most importantly appears on the notified products list. This process can take up to six months. Please reference the MHRA’s latest bulletin here: https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products#advice-for-retailers

Yes. The MHRA has updated the language on its retailer advice sections as follows:

Old version:

Advice for retailers

When sourcing new supplies of any e-cigarette or e-liquid product, check that details of the notification for the product have been published in the list of Notified Products.

If you cannot find the product on the MHRA’s website, ask your supplier to confirm that the product complies with the TRPR and has been notified to the MHRA. If a producer has not notified the product or it does not comply with the TRPR, they may not supply it to you.

New Version updated Aug 2021

Advice for retailers

When sourcing new supplies of any e-cigarette or e-liquid product, check that a compliant notification has been published in one of the Notified Product lists above.

If you cannot find the product on the MHRA’s website, ask your supplier to confirm that it has been published and provide details to enable you to confirm the products status. If a product has yet to achieve publication status, they may not supply it to you.

Yes, all nicotine devices are covered by the TRPR regulations.

Yes, as a reseller of these products it is your responsibility to check. If you are selling products that do not comply with the TRPR you are liable to have your products seized and face prosecution. Your supplier must provide you with proof that the products have been published on the MHRA’s notified products list. https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products#notified-products-for-great-britain-and-northern-ireland

No, the maximum nicotine strength that is legal in the UK and EU is 2% or 20mg. You may face your goods being confiscated and face prosecution for selling such products in the UK.

Puff rates will vary from device to device; however it is unlikely that you could get a puff rate in excess of between 500-600 from a legal 2ml tank.  For example, devices such as the Geekbar Pro and Elbar 1,500 puff are not legal for sale in the UK.

You can follow this link to the MHRA’s advice for retailers Link : E-cigarettes: regulations for consumer products – GOV.UK (www.gov.uk)

To supply new E-cigarette products in Great Britain (England, Scotland and Wales) and Northern Ireland you must notify your products via the appropriate notification system for each region. To supply a product to Great Britain you are required to notify using the MHRA submission portal. To supply a product to Northern Ireland you will continue to use EU-CEG. 

Once you have successfully submitted your notifications, they will be reviewed for compliance by the MHRA. If the notification meets the required standards it will be published here. Once your product notification has been published you will be able to legally supply the goods in the region for which they have been notified.

Please note that it is an offence to supply any notifiable product until the notification has been completed and published on the MHRA website. Unnotified products that have not been included on the published lists may be subject to seizure by enforcement authorities.

If you are currently supplying a product that has not been notified and published, you should complete a notification immediately, following the guidance below. All affected products must be withdrawn from supply until publication has been achieved.  

You need to have signed up for an account with the MHRA submission portal. if you have not already, we would recommend doing this as soon as possible. 

Further guidance on the new process can be found here. You can also watch our recent webinar video for more information.

More detailed information on this process can be found on our webpage

Guidance on the content of notifications 

The guidance for Northern Ireland is unchanged. 

Great Britain no longer recognises authorised representatives and responsible persons based in the EU. 

If the company making a notification does not have a base in the UK, you will need to appoint an authorised representative or responsible person based in the UK for products being placed on the GB market. As a submitter you are required to provide this information to the MHRA via the GB Submission Portal. This information should be added to the “Affiliate Company” field in Submitter Information for each product notification. Failure to provide this information may constitute an offence under the Regulations and will significantly delay the publication of affected product notifications.  

If you are notifying a product for supply to Northern Ireland and have already provided details of an EU or NI based responsible person via EUCEG then no further action is required for NI notifications. 

Manufacturers 

You are responsible for: 

  • ensuring your product complies with the relevant UK rules 
  • drawing up documentation 
  • submitting a notification for the product  
  • You can delegate some of the duties to an authorised representative or an importer if you are based outside the UK  

UK distributors and suppliers 

Where a product is not manufactured in the UK, you’ll need to confirm whether you or your supplier will act as an ‘importer’.

You are an importer if you’re the first one bringing goods from outside the UK and placing them on the market in Great Britain and/or Northern Ireland. If someone has already placed a product on the UK market before you sell it in Great Britain and Northern Ireland – or if the manufacturer has appointed another UK-based person to carry out importer duties – you will remain a distributor and will not have any additional responsibilities. 

As an importer, you’ll need to make sure that: 

  • goods are labelled with your company’s details, including your company’s name and a contact address.  
  • the correct conformity assessment procedures have been carried out and that goods have the correct conformity markings 
  • the manufacturer has drawn up the correct technical documentation and you or they have complied with the product labelling requirements 
  • goods conform with the relevant essential requirements 
  • goods have been appropriately notified to MHRA and the notifications published 

For detailed requirements regarding the importation and supply of manufactured products please review the current UK Government guidance for Great Britain and Northern Ireland

The MHRA now provides an online service for the payment of E-cigarette notifications. Invoices can be paid using a debit or credit card and your invoice number which is located below your address on the invoice. We accept all major debit and credit cards including Visa, Mastercard, Maestro and American Express. Payment of invoices is due immediately upon receipt. 
Payments can be made in British Pounds Sterling only. 

If you have not received an invoice, or have any queries please contact the MHRA Accounts Receivable team at sales.invoices@mhra.gov.uk 

Please note that assessments and publication of your notifications can not proceed until invoices are paid in full.

We have been in touch with submitters where we have identified conflicts and are working with them to resolve conflicts. It is of upmost importance that we receive a response as soon as possible in these instances. 

Below are some troubleshooting steps to follow should you encounter any of the listed issues:  

  1. Applicants that already have a submitter ID in EU system

Whilst making a submission on MHRA submission portal if you find the portal is providing an option to generate new submitter ID instead of pre-populating your EU submitter ID then instead of progressing with the submission please report this to MHRA via the ‘Help and Support’ tile on MHRA submission portal.  

  1. Applicants do not agree with the company name on MHRA submission portal

Once you have validated the submitter ID assigned by MHRA submission portal and it is in line with your EU submitter ID then you will have an option to raise a request to update your company display name. A request can be raised via the ‘Help and Support’ tile.   

NOTE – The company name displayed on the MHRA submission portal is also used in the extract published on our MHRA gov website.  

  1. Change of ownership

If your company ownership has changed and you require a new 5-digit MHRA company number for the MHRA Submissions Portal please raise a request via the Reference Data Team  

Please be sure to include as much of the information below as possible in your email:

  • Full legal entity/company name (no abbreviations, trading styles or short names please) 
  • Headquarters address 
  • Bill To/Invoicing address (If different from the Headquarters address.) 
  • Invoicing email address 

For general enquiries please contact our Customer Services team:  info@mhra.gov.uk

If you have any questions about the notification status of your products, please send them directly to our TPD mailbox: TPDnotifications@mhra.gov.uk

To update company contact details email: Reference.Data@mhra.gov.uk

For queries regarding invoices and payments email our Finance team: sales.invoices@mhra.gov.uk

For any safety concerns contact our Vigilance team: TPDsafety@mhra.gov.uk

If you encounter any technical difficulties while using the EU-CEG portal, please contact the EU commission IT helpdesk at SANTE-EUCEG-ITSUPPORT@ec.europa.eu (including in your message a ‘print screen’ of the window where the problem appears). 

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